NCT00995839

Brief Summary

The present study was conducted as a prospective, randomized study to investigate the effects of vasopressin receptor agonists terlipressin and vasopressin on systemic hemodynamics and microcirculation in patients with catecholamine-dependent septic shock.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 4, 2010

Status Verified

October 1, 2009

Enrollment Period

1.3 years

First QC Date

October 14, 2009

Last Update Submit

February 3, 2010

Conditions

Septic ShockSepsis

Keywords

terlipressinvasopressinsepsisseptic shocknorepinephrine

Outcome Measures

Primary Outcomes (2)

  • Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI)

    over a period of 6 hrs from the time of randomization

  • Oxygen transport variables

    over a period of 6 from the time of randomization

Secondary Outcomes (5)

  • Acid-base homeostasis

    over a period of 6 hrs from the time of randomization

  • Functional capillary density (mm/mm2) (FCD)

    over a period of 6 hrs from the time of randomization

  • De Backer score

    over a period of 6 hrs from the time of randomization

  • Perfused Vessel Density (PVD) (mm/mm2)

    over a period of 6 hrs from the time of randomization

  • Proportion of Perfused vessels (%) (PPV)

    over a period of 6 hrs from the time of randomization

Study Arms (3)

continuous terlipressin

EXPERIMENTAL
Drug: continuous infusion of terlipressin

vasopressin

EXPERIMENTAL
Drug: Arginine vasopressin

terlipressin bolus dose

EXPERIMENTAL
Drug: terlipressin bolus administration

Interventions

continuous infusion of terlipressinDRUG

Intravenous continuous infusion of terlipressin 1 µg•kg-1•h-1 for 6 hrs

continuous terlipressin
Arginine vasopressinDRUG

Intravenous continuous infusion of arginine vasopressin 0.04 UI•min-1 for 6 hrs

vasopressin
terlipressin bolus administrationDRUG

intravenous terlipressin bolus administration at the dose of 0.5 mg

terlipressin bolus dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of septic shock
  • Vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)

You may not qualify if:

  • Pregnancy
  • Age \< 18 years
  • Present or suspected acute mesenteric ischemia
  • Vasospastic diathesis (e.g. Raynaud's syndrome or related diseases)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Anesthesiology and Intensive Care

Rome, I, 00161, Italy

Location

Related Publications (1)

  • Morelli A, Donati A, Ertmer C, Rehberg S, Kampmeier T, Orecchioni A, Di Russo A, D'Egidio A, Landoni G, Lombrano MR, Botticelli L, Valentini A, Zangrillo A, Pietropaoli P, Westphal M. Effects of vasopressinergic receptor agonists on sublingual microcirculation in norepinephrine-dependent septic shock. Crit Care. 2011;15(5):R217. doi: 10.1186/cc10453. Epub 2011 Sep 19.

    PMID: 21929764DERIVED

MeSH Terms

Conditions

Shock, SepticSepsisDiabetes Insipidus

Interventions

Arginine Vasopressin

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

VasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Andrea Morelli, MD

    University of Rome "La Sapienza", Department of Anesthesiology and Intensive Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 15, 2009

Study Start

November 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 4, 2010

Record last verified: 2009-10

Locations

IT(1)